Legal foundations in the field of plant protection products
The evaluation, authorisation, labelling and application of plant protection products are regulated by a number of laws and ordinances, whereby European regulations in particular play a key role.
EU approval of active substances and authorisation of plant protection products
The approval of active substances and the authorisation of plant protection products have been regulated since 2011 by Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market. The regulation also specifies the updated data requirements and decision-making criteria for the authorisation of plant protection products in the member states.
The measures introduced by the regulation in Europe include:
- Zonal authorisation: this procedure regulates the authorisation of plant protection products in multiple countries simultaneously or consecutively
- Cut-off criteria for active substances: active substances can only be used in plant protection products if, for example, they are not classified as carcinogenic, mutagenic or toxic to reproduction in GHS category 1A or 1B.
- A negative list of co-formulants which are no longer authorised
- Harmonisation of assessment procedures within the EU including uniform time-frames
Regulation (EU) No 1107/2009 replaced Council Directive 91/414/EEC on 14 June 2011. Since then, active substances approved in the EU have been listed in Implementing Regulation (EC) No 540/2011 and its amendments. Active substances that were approved in accordance with Annex I to the replaced Council Directive 91/414/EEC were also included in this list.
The data requirements for the evaluation of active substances to be used in plant protection products are covered by Regulation (EU) No 283/2013. This regulation also stipulates, for example, that active substances of plant protection products must undergo the following very extensive tests for potentially damaging effects on health: toxicokinetics and metabolism, acute toxicity, skin and eye irritation, sensitisation, subchronic toxicity, genotoxicity, chronic toxicity, carcinogenicity, reproductive and developmental toxicity, neurotoxicity and endocrine disrupting properties. Further studies, e.g. on toxicological mechanisms of action, are to be carried out if necessary.
The scope of toxicological tests for plant protection products is regulated by law in Regulation (EU) No 284/2013. In addition to the data already presented in active substance testing, the following effects are assessed for the plant protection product up for authorisation: acute toxicity (oral, dermal, inhalation), irritation of the skin and eyes, skin sensitisation and dermal absorption (uptake via the skin). If necessary, further examinations are to be carried out on combination effects of the ingredients found in the plant protection products.
Maximum residue levels
Residue levels of active substances in food and feed are regulated by Regulation (EC) No 396/2005 and its adaptations. In Annex I to this regulation, all food products and - in the future - feed are listed for which maximum residue levels have been set. Annex II and III to the regulation list the valid maximum residue levels for all combinations of active substances and food.
Additional relevant EU regulations
For the classification and labelling of active substances and plant protection products, Regulation (EC) No 1272/2008 (CLP Regulation) applies.
For the application of plant protection products, the directive establishing a framework for Community action to achieve the sustainable use of pesticides (Directive 2009/128/EC) must also be taken into account.
Plant protection products which can be used in organic production are listed in Regulation (EC) No 834/2007.
At national level, the German Plant Protection Act applies. This legislation regulates, among other things, the responsibilities of the authorities in Germany. The details are regulated by a number of ordinances such as the Plant Protection Products Regulation, the Regulation on Plant Protection Equipment or the Plant Protection Ordinance Governing Specialist Qualifications. There is also the National Action Plan on Sustainable Use of Plant Protection Products as well as the rules for good plant protection practice.
Test guidelines and guidance documents
The legally prescribed data requirements for the approval of active substances and the authorisation of plant protection products stipulate the guidelines that must be followed for the corresponding tests on active substances or plant protection products. These are generally internationally harmonised test guidelines from the OECD or EU, according to which the applicants (usually manufacturers) must carry out and submit the relevant studies under GLP conditions. The assessment authorities decide whether to accept the submitted studies under consideration of the requirements set out in the OECD or EU test guidelines.
The health risk assessments of the active substances and plant protection products carried out by the authorities also follow EU or OECD-wide harmonised guidance documents. These are developed based on the current state of the art in science and technology and are adapted if necessary. A compilation of the currently valid test guidelines and guidance documents (PDF file,92.55 KB) most important for the health assessment by BfR is available for download as a PDF file.